Jr Quality Assurance and Regulatory Affairs

il y a 5 jours

Paris, France DentalMonitoring Temps plein

DentalMonitoring is a MedTech scale-up in a fast-growing medical field. We are looking for new talent to join our team

**What is the added value of Dental Monitoring’s solutions for its clients
✦ Our SAAS monitors and optimizes orthodontic treatment for doctors and patients alike using our app and patient platform

✦ DentalMonitoring brings the first AI-driven technology in the oral healthcare space

✦ With more than 200 filed patents on our technology, we are leading an entire industry in how we approach the orthodontic experience

✦ Our handy tool, the Scanbox, helps patients and doctors to easily detect intraoral observation

✦ Their patients smile again

Dental Monitoring was promoted in the Next40 for the second year in a row.

This position is open to Juniors / entry level.

**The Jr **RA/QA Specialist Role
✦Participates in communication inside and outside the company to educate your Dental Monitoring colleagues and clients regarding quality & regulatory requests.
✦Ensures that the quality system is maintained or updated in compliance with ISO 13485 and ISO 27001 and other future applicable quality (MDSAP) or regulatory requirements.
✦Leads the use in the company of a quality system software to improve traceability, maintenance and avoid wasting time by an automatization of low added value actions
✦Reviews corporate quality KPI and prepare quality management reviews, including Oversight of key quality processes, including Internal/External audit, Supplier Quality, CAPA,
✦Post-Market Surveillance (Complaints, Field Action), Change Control, Data & Documentation Management, Training and Product Release.
✦Maintains registrations after the product is placed on the market.
✦Ensures communication with competent authorities.
✦Defines the labelling and check promotional material
✦Ensures the needed regulatory & quality assurance watch

The above is not an exhaustive list of all duties, responsibilities and qualifications associated with the job. Other duties may be assigned.

**You will be successful in this role if you have**

✦0-2 years of experience in related area.

✦Engineering Degree or Pharmacist or MsC in Regulatory Affairs or Medical/Scientific field.

✦Ability to communicate effectively and build relationships with internal/external stakeholders.

✦Excellent organisation, rigour and analytical skills

✦Proficient in oral and written English

**It would be fantastic if you have**

✦Experience in a startup or scale-up environment

✦Knowledge in international regulation other than CE & USA regarding medical devices such as MDSAP

✦Other languages than French and English

✦Experience in the dental area

**Our work environment**

At Dental Monitoring our employees thrive because:
✦ We are collaborators It is a core value and our team of researchers, doctors, developers, salespeople and all of our stakeholders work together to put our customers first

✦ DentalMonitoring is a diverse, multicultural company: you can find more than 20 nationalities throughout our teams

**What we bring to our employees**

✦ Your ideas will be heard Our culture promotes initiatives, ownership and feedback

✦ Everyone is committed to supporting your professional development because we understand that no one can know everything

✦ We place significant importance on the quality of work-life balance

✦Here are some perks that we offer our employees: Alan health insurance, Swile card, Free shares plan, Hybrid work, Gymlib, Corporate events, Referral policy

**This role is Paris office based

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